The present invention relates generally to packaging of unit-dosage drug formulations, and more particularly in providing a package that both satisfies the U.S. Poison Prevention Packaging Act regarding child-resistance, and provides a safe, sturdy, and economical package for the transport and dispensing of drug formulations.
Recent Federal legislation has been enacted requiring manufacturers to provide child-resistant packaging. The U.S. Poison Prevention Packaging Act was enacted to safeguard children from self-administering pharmaceuticals that may pose a danger to them. The marketplace contains many children's formulations that are made to be palatable, but with the unfortunate side-effect that this predisposes children to believing that any pills or liquids in bottles will taste good, and do not present a danger.
It is desirable to provide a package form that is both easy to use for adults, protective for the pharmaceutical within, and difficult for children to open. The package of the present invention is easy to open for an adult, access being facilitated by entry at discrete points, with many steps necessary to access the drug form within. This method of access is both obvious to an adult, yet inhibitory to a child. The material forming the blister package is sufficiently strong such that even an adult would have great difficulty in tearing it without utilizing the prearranged scheme for tearing across the perforated score lines. The blister package is sturdy enough for fragile drug forms, provides protection from physical stresses, and is also moisture resistant. These considerations are important for pharmaceuticals formed by lyophilization, or "freeze-drying". The dosage form may be a capsule, tablet, Gelcap.TM. capsule or the like. The invention is also comprised of a water-tight lidding sheet, which must be peeled back to expose the dosage form within. Access to the fragile drug forms is inhibited to children by allowing for only limited entry points on the blister package, combined with sequential performance of a number of steps to obtain access to a single dosage form.